An interventional study of serological testing in SARS-CoV Infection, sponsored by Universitair Ziekenhuis Brussel. Active, not recruiting at 1 site in Belgium. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-05-18.
Sponsored by Universitair Ziekenhuis Brussel · Not applicable, Interventional, and Diagnostic
A novel zoonotic coronavirus was discovered in Wuhan (Hubei Province, China) mid-December 2019 and was named severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The virus rapidly spread to the rest of the world, including Europe and explicitly affects the respiratory system, generating Coronavirus disease 2019 (COVID-19).
This study is a monocentric interventional prospective and retrospective cohort study. After signing a written informed consent, participants will be recruited for questionnaire completion and blood sampling. Sample storage and analysis will be performed at the laboratory of microbiology of the UZ Brussel.
To document SARS-CoV-2 seroprevalence and seroconversion among employees of the UZ Brussel after mRNA vaccination for SARS-CoV-2, namely at 8 weeks after first vaccination, 6 months after first vaccination and 12 months after first vaccination.
A novel zoonotic coronavirus was discovered in Wuhan (Hubei Province, China) mid-December 2019 and was named severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The virus rapidly spread to the rest of the world, including Europe and explicitly affects the respiratory system, generating Coronavirus disease 2019 (COVID-19).
UZ Brussel employees presenting symptoms suggestive of COVID-19 are offered to be tested with real-time PCR on nasopharyngeal swabs. As asymptomatic infections have been described and as the PCR can be negative when taken late after onset of symptoms, serologic tests can be performed. The SARS-CoV 2003 epidemic demonstrated that serological assays were a useful diagnostic tool of non-acute infections. Although it is still uncertain whether convalescing patients have a risk of re-infection, recent data suggest that SARS-CoV-2 antibodies could protect at least for some time from subsequent viral exposures.
As the COVID-19 pandemic had devastating medical, economic and social consequences, safe and effective prophylactic vaccines were urgently needed. And thus several candidate vaccines against SARS-CoV-2 have been developed. During the first weeks of the vaccination campaign, the health care workers of the UZ Brussel, were invited to receive the BNT162b2 (Pfizer) vaccine.
Consequently, the investigators aim to prospectively document the SARS-CoV-2 seroprevalence and seroconversion among vaccinated employees of the UZ Brussel, at three different time points, namely 6 weeks (+/- 2 weeks; T1), 6 months (+/- 1 month; T2) and 12 months (+/- 1 month; T3) after the second vaccination.
382 studies on the registry are indexed under Severe Acute Respiratory Syndrome; 14 are open to participants now.
This study's enrollment of 500 is above the median of 150 across 213 interventional studies indexed under Severe Acute Respiratory Syndrome.
Browse Severe Acute Respiratory Syndrome studies →Universitair Ziekenhuis Brussel is the lead sponsor of 362 studies on the registry; 103 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
All patients follow this arm. Patients will undergo 3 blood sample testings at 3 different time points and have to fill in a questionnaire at 3 different time points
Diagnostic Test: serological testing
Antibody testing for Sars-COV-2 antibodies in blood.
seroprevalence
To document SARS-CoV-2 seroprevalence among employees of the UZ Brussel after mRNA vaccination for SARS-CoV-2, at 8 (+/- 2) weeks after the first vaccination (T1); and 6 and 12 months after the first vaccination (T2 and T3) using a validated immuno-assay for detection of SARS-CoV-2 IgG antibodies
Time frame: Change from baseline to 8 weeks, 6 months and 12 months timepoint
Seroconversion
To document SARS-CoV-2 seroconversion among employees of the UZ Brussel after mRNA vaccination for SARS-CoV-2, at 8 (+/- 2) weeks after the first vaccination (T1); and 6 and 12 months after the first vaccination (T2 and T3) using a validated immuno-assay for detection of SARS-CoV-2 IgG antibodies
Time frame: Change from baseline to 8 weeks, 6 months and 12 months timepoint
SARS-CoV-2 seroprevalence before and after vaccination
To compare the SARS-CoV-2 seroprevalence before vaccination with the SARS-CoV-2 prevalence after vaccination among employees of the UZ Brussel.
Time frame: Change from baseline to 8 weeks, 6 months and 12 months timepoint
incidence of new definite cases
To document the incidence of new definite cases of COVID-19 (based on self-reported positive PCR testing on nasopharyngeal swab) among vaccinated employees of the UZ Brussel over a period of a year.
Time frame: Change from baseline to 8 weeks, 6 months and 12 months timepoint
incidence of new probable cases
To document the incidence of new probable cases of COVID-19 (based on the study questionnaire filled in by the participants) among vaccinated employees of the UZ Brussel over a period of a year.
Time frame: Change from baseline to 8 weeks, 6 months and 12 months timepoint
antibody kinetics and antibody neutralisation capacity
To document the SARS-CoV-2 antibody kinetics and antibody neutralisation capacity after vaccination.
Time frame: Change from baseline to 8 weeks, 6 months and 12 months timepoint
antigen-specificity of the SARS-CoV-2-specific T cells
To determine the antigen-specificity of the SARS-CoV-2-specific T cells as well as their phenotype and functionality.
Time frame: Change from baseline to 8 weeks, 6 months and 12 months timepoint
Plan to share: No
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This study is active, not recruiting, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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Severe Acute Respiratory Syndrome→
Universitair Ziekenhuis Brussel